Federal Register #2026-20441

FDA Classifies Masimo Hyperoxia-Monitoring Device as Class II

The U.S. Food and Drug Administration classified a hyperoxia-monitoring device used alongside pulse oximetry as a Class II medical device. - Government agency: U.S. Department of Health and Human Services, Food and Drug Administration (FDA). No sub-agency or office is identified. - Nature of action: Regulatory classification following a De Novo request from Masimo Corporation; this is not a procurement or contract award. - Device: Hyperoxia monitoring device adjunct to pulse oximetry, intended to monitor elevated hemoglobin oxygen saturation levels alongside arterial oxygen saturation monitoring. - Requirements: Class II classification with special controls covering clinical performance, human factors and usability, electrical safety and electromagnetic compatibility, biocompatibility, reprocessing validation, software verification and validation, pulse-oximeter compatibility, and labeling. Premarket notification requirements also apply. - Products, quantities, and services: No purchase quantities, part numbers, or services are specified.

Description

The FDA is classifying the hyperoxia monitoring device adjunct to pulse oximetry as a class II device subject to special controls. The device monitors elevated hemoglobin oxygen saturation levels as an adjunct to arterial oxygen saturation monitoring. The order establishes special controls addressing clinical performance, usability, electrical safety and electromagnetic compatibility, biocompatibility, reprocessing, software, and labeling. The order is effective October 6, 2026, and states that the classification was applicable on October 12, 2023.

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